Transdermal patches containing nicotine have been tested, approved and marketed as nicotine replacement products. Reported methods for using such transdermal patches typically utilize fixed, non-aggressive dosage regimens, some of which include tapering of the level of nicotine in the transdermal patches over the course of the treatment period. For example, the labeling of some products impose fixed tapering dosing schemes which utilize transdermal patches containing about 21 milligrams (mg) of total absorbable nicotine for 6 weeks, transdermal patches containing about 14 mg of total absorbable nicotine for 2 weeks, and transdermal patches containing about 7 mg of total absorbable nicotine for 2 weeks. Other reported methods utilize a fixed dosing scheme, i.e. there is no tapering of the amount of absorbable nicotine present in the transdermal patch. For instance, it has been reported to use transdermal patches containing about 15 mg of absorbable nicotine for 6 weeks.
Two published clinical studies compare quit rates for 22 mg and 44 mg patches. Neither study demonstrated a statistically significant difference in long term quit rates, though end of treatment success rates were significantly higher in those receiving the 44 mg dose. However, a sub-analysis suggested that in patients receiving minimal smoking cessation guidance, the 44 mg dose produced greater abstinence than did the 22 mg dose (68% vs. 45%, p&lt;0.01) at the end of 4 weeks of treatment. Patients receiving individual or group counseling did not demonstrate this significant effect. Other studies suggest that smokers who use standard-dose nicotine patches as directed, who have few adverse effects, and who relapse because of persistent nicotine withdrawal symptoms or craving should be considered for dosages higher than 21 mg per day of standard patch therapy.
Two publications have reported higher quit rates when nicotine patches, used according to conventional teachings, were supplemented with nicotine gum.
There is consistent evidence from existing clinical trials that currently reported dosing schemes utilizing transdermal nicotine patches alone provides less than adequate nicotine replacement in most smokers. While it has been shown that at one year after initiation of reported nicotine treatment methods, successful quit rates are twice those of placebo, nevertheless, even with treatment by a general practitioner, less than 1 out of 4 attempts to cease using tobacco are successful in the first 2-3 months of a cessation attempt when reported methods of treatment are used.
Irregardless of which reported method is used, at the end of the conventional, pre-determined and fixed treatment period, there is no provision or consideration for those "treated" patients who either have exhausted the conventional treatment methods, yet still have the need to use tobacco products, or have failed to complete the conventional treatment methods due to their unabated need to use tobacco products. Accordingly, improved methods of treatment to eliminate or substantially reduce the need in humans to use tobacco are desirable.